Electrolyte gels for maintaining hydration and rehydration

ABSTRACT

A gel rehydration electrolyte composition provides a convenient and effective way of replenishing lost fluid and electrolytes. The gel rehydration electrolyte composition masks unpleasant tastes of electrolyte and is readily consumed by young children and elderly who cannot tolerate the liquid or frozen forms of electrolytes.

FIELD OF THE INVENTION

[0001] The invention comprises a gel electrolyte composition for theoral replacement of electrolytes in the body. In particular, theinvention relates to a gel rehydration electrolyte composition. The gelrehydration electrolyte composition provides a convenient and effectivevehicle for orally administering electrolytes in a way that is readilytolerated by infants, young children, and elderly patients who havedifficulty tolerating liquid or frozen forms of electrolytes.

BACKGROUND OF THE INVENTION

[0002] Electrolyte solutions are conventionally used to orally replaceelectrolytes lost during vomiting or diarrhea or as a result ofexercise. Electrolyte loss thorough diarrhea and vomiting in particularcan cause a severe condition, especially in infants and young children,and may result in death. Diarrhea frequently involves colonization ofthe small intestine with enteropathogenic strains of E. Coli whichproduce heat stable and/or heat labile enterotoxins. Relatedenterotoxins are produced by other enteropthogens such as cholera, andalso cause diarrhea. These enterotoxins stimulate fluid secretion in thegut lumen and cause diarrhea. Associated fluid loss may lead to death.

[0003] In cases of severe dehydration corrective parenteral(intravenous) therapy is often necessary. In cases of mild to moderatedehydration, oral rehydration solutions provide a safe and economicalalternative to intravenous therapy. Oral electrolyte solutions used inoral maintenance or rehydration therapy consist of a mixture ofelectrolytes and a carbohydrate component such as glucose or dextrose.Examples of commercially available oral electrolyte replacement and/ormaintenance solutions include Rehydroltye® and Pedialyte®, manufacturedby Ross Laboratories, Columbus, Ohio, and Magonate® Liquid, manufacturedby Fleming and Company, Fenton, Mo. Frozen formulations of electrolytessold by PTS Labs have been found to be particularly advantageous inadministering electrolytes to children. See, e.g., Santucci et al.,Frozen Oral Hydration as an Alternative to Conventional Enteral Fluids.Archives of Pediatrics & Adolescent Medicine, February 1998, Vol. 152,pp. 142 to 146.

[0004] The development of oral rehydration therapy for acute diarrhealdiseases of infancy and childhood has significantly reduced relatedmorbidity and mortality, particularly in less developed countries whereit constitutes the primary mode of therapy. The World HealthOrganization (WHO) currently recommends that oral rehydration solutionsfor treatment of acute diarrheal therapy contain 90 mEq sodium/liter, 20mEq potassium/liter, 80 mEq chloride/liter, 30 mEq citrate/liter or 30mEq bicarbonate/liter, and 110 mmol glucose/liter. Glucose isrecommended as the carbohydrate component in such oral rehydrationsolutions. Glucose enhances the membrane transport of sodium, which inturn enables rapid uptake of water. The WHO formulation has been shownto decrease morbidity and mortality.

[0005] Substitution of other carbohydrates for glucose in WHO-typeformulations has been investigated. Lebenthal et al. (J. Pediatrics,1983, 103:29-34) studied the effect of three corn syrup sugars(dextrins) containing glucose polymers of varying lengths havingdextrose equivalents of 10, 15 and 24 and determined they were suitableas the sole carbohydrate source in oral rehydration therapy. It has alsobeen established that oral rehydration solutions in which rice and otherfood sources of starch are substituted for glucose are effective asreported by Carpenter et al. (New England J. Med., 1988, 319:1346-1348).Rice-based oral rehydration solutions containing from 3 to 5% rice andhaving electrolyte levels corresponding to conventional WHO formulationshave been found to be effective as reported by Patra et al. (Archives ofDisease in Childhood, 1982, 57:910-912), Molla et al. (The Lancet, 1982,1317-1319), and El Mougi et al. (Journal of Pediatric Gastroenterologyand Nutrition, 1989, 8:81-84). U.S. Pat. No. 5,096,894 discloses an oralrehydration solution comprising a mixture of the required electrolytesand rice dextrin containing a distribution of 50-90% short chain glucosepolymers consisting of 2 to 6 glucose units.

[0006] U.S. Pat. No. 5,270,297 discloses an oral rehydration solutionincluding a blend of simple sugars, more complex carbohydrates, andminerals, particularly magnesium. Other ingredients include electrolyteions (e.g., potassium, sodium, chloride), vitamins, anabolic nutrients,and other minerals such as calcium. The magnesium and calcium areprovided in the form of amino acid chelates to facilitate rehydrationand promote endurance.

[0007] U.S. Pat. Nos. 4,505,926, 4,539,319, 4,558,063 and 4,594,195disclose various oral rehydration solutions containing pharmaceuticallyactive ingredients (i.e., drugs) for treatment for enterotoxin induceddiarrhea and prevention of death from enteropathogenic E. coli infectionof gastro-intestinal tract. Drugs incorporated into these prior artrehydration solutions include quaternary aminophenyliminoimidazolidines,2-amino-immidazoline derivative, and 5,6,7,8-tetrahydro-naphonitrileintermediates.

[0008] U.S. Pat. No. 4,942,042 is directed to an anti-diarrheacomposition comprising an absorptive component and an electrolyte/sugarcomponent. The absorptive material is a thermally activated, finelypowdered, hydrous magnesium aluminum silicate clay capable of absorbingpathogenic intestinal bacteria. The absorptive material is preferablyalso capable of absorbing diarrhea-associated viruses, intestinal toxinsand gases. Suitable absorptive materials are clays such as Smectite(Si₈Al₄O₂₀OH₄). Other such clays are argillaceous clays. Theelectrolyte/sugar component contains a sodium salt, a potassium salt anda sugar. The composition is packaged in solid form and reconstituted byadmixture with water prior to administration.

[0009] U.S. Pat. No. 5,192551 discloses rehydration and infant nutrientformulas containing a neutral glycolipid, in particular,gangliotetracosylceramide. The glycolipid binds enteric virus, e.g.,rotairuses, which are pathogenic to humans. Rotaviruses are RNA virusesknown to replicate in the intestinal epithelial cells of a wide range ofanimal species, including humans.

[0010] Frozen electrolyte compositions and delivering systems aredescribed in U.S. Ser. No 08/786,072, which is incorporated herein byreference.

[0011] Electrolytes generally have a disagreeable taste. As such,rehydration/electrolyte solutions are often difficult to administer,especially to young children. While unflavored or flavored oralelectrolyte maintenance and replenishing solutions for infants andchildren are available, such as Fruit-Flavored Pedialyte® manufacturedby Ross Laboratories, Columbus, Ohio, frozen electrolyte formulations(such as Revitalice® sold by PTS Labs, Lake Forest, Ill.) have beendemonstrated to be better tolerated in administering electrolytes tochildren. However, even the frozen electrolytes are in some instancesnot suitable for young children or elderly patients. This invention isdirect at fulfilling this need.

SUMMARY OF THE INVENTION

[0012] The invention is directed to a gel electrolyte composition fororal administration of electrolytes. More particularly, the invention isdirected to a gel rehydration electrolyte composition useful in themaintenance and/or replacement of electrolytes lost through diarrhea,vomiting, during physical exercise, or through other illness. Whereasall prior art oral rehydration solutions are administered in a liquid orfrozen form, the composition of the invention is designed to be servedin a gel form.

[0013] Thus, in a first aspect, the invention provides a gel rehydrationelectrolyte composition comprising:

[0014] (a) from about 80 to about 99 percent by weight water;

[0015] (b) from about 20 to about 60 mEg of sodium per liter of water;

[0016] (c) from about 15 to about 25 mEq of potassium per liter ofwater;

[0017] (d) from about 25 to about 50 mEq of chloride per liter of water;

[0018] (e) from about 20 to about 50 mEq of citrate per liter of water;

[0019] (f) from about 20 to about 30 grams of carbohydrate per liter ofwater; and

[0020] (g) from about 2 to about 10 grams of a structuring agent perliter of water.

[0021] In another aspect, the invention provides a gel rehydrationelectrolyte composition comprising a structuring agent that is acombination of carrageenan and locust bean gum.

[0022] In still another aspect, the invention provides a gel rehydrationelectrolyte composition that is a gel at room temperature, i.e. notfrozen.

[0023] In a further aspect, the invention provides a dry powder whichupon the addition of an amount of water provides a gel rehydrationelectrolyte composition comprising:

[0024] (a) from about 80 to about 99 percent by weight water;

[0025] (b) from about 20 to about 60 mEg of sodium per liter of water;

[0026] (c) from about 15 to about 25 mEq of potassium per liter ofwater;

[0027] (d) from about 25 to about 50 mEq of chloride per liter of water;

[0028] (e) from about 20 to about 50 mEq of citrate per liter of water;

[0029] (f) from about 20 to about 30 grams of carbohydrate per liter ofwater; and

[0030] (g) from about 2 to about 10 grams of a structuring agent perliter of water.

[0031] In yet a further aspect, the invention provides a method ofreplacing lost electrolytes or preventing loss of electrolytescomprising orally administering to an individual in need thereof a gelrehydration electrolyte composition comprising:

[0032] (a) from about 80 to about 99 percent by weight water;

[0033] (b) from about 20 to about 60 mEg of sodium per liter of water;

[0034] (c) from about 15 to about 25 mEq of potassium per liter ofwater;

[0035] (d) from about 25 to about 50 mEq of chloride per liter of water;

[0036] (e) from about 20 to about 50 mEq of citrate per liter of water;

[0037] (f) from about 20 to about 30 grams of carbohydrate per liter ofwater; and

[0038] (g) from about 2 to about 10 grams of a structuring agent perliter of water.

[0039] These and other aspects of the invention will become apparent inlight of the detailed description below.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

[0040] The gel rehydration electrolyte composition of the inventioncontains all necessary electrolytes and levels thereof required by theAmerican Academy of Pediatrics for oral rehydration formulations sold inthe United States. In addition to sodium (Na⁺), potassium (K⁺), chloride(Cl) and citrate ions, the gel rehydration electrolyte compositioncontains a source of carbohydrate such as glucose or dextrose to controlabsorption of electrolytes and contains a structuring agent to provide agelled or thickened composition. Fruit flavoring and sweeteners designedto mask the unpleasant tastes of electrolytes are also provided in thegel rehydration electrolyte compositions of the invention.Administration in the gel form also has been discovered to lessen theoffensive taste of electrolytes.

[0041] The invention provides the art with a gel rehydration electrolytecomposition for replacement or prevention of electrolyte loss throughoral administration. The composition comprises a structuring agentcomprising a gelling and/or thickening agent such as gum or gelatin,water, carbohydrate, sodium ions, potassium ions, chloride ions, andcitrate ions in concentrations effective in replacing electrolytes indehydrated subjects.

[0042] The invention also provides a method of replacing lostelectrolytes or preventing loss of electrolytes where the liquid orfrozen forms of the electrolyte are not suitable. The method comprisesorally administering to an individual in need thereof a gel rehydrationelectrolyte composition comprising a gelling or thickening agent, water,carbohydrate, sodium ions, potassium ions, chloride ions and citrateions in concentrations used in the liquid or frozen form.

[0043] Young children on occasion either will not drink electrolyteliquids or have a propensity to bite off large chunks of ice fromfreezer pops. However, the gel rehydration electrolyte compositioncomprising necessary electrolytes can readily be administered to youngchildren in need of such electrolytes. Elderly also have difficulty withthe intake of both liquid and frozen electrolytes and benefit from thegel rehydration electrolyte composition of this invention. In eitherpediatric or geriatric cases, the gel rehydration electrolytecompositions offer an effective alternative to liquids or freezer popswith patients who either will not drink, have difficulty keepingingested material down, or cannot self-administer.

[0044] When children are sick, the usual foods and liquid are frequentlyreduced or discontinued, often producing a loss of essential fluids andelectrolytes. Vomiting and diarrhea can result in further loss ofessential fluids and electrolytes. In order to forestall dehydration andprevent fluid losses before serious deficits develop, replacementtherapy is often required.

[0045] The gel rehydration electrolyte composition provides, in aconvenient dosage form, a balanced formula of important electrolytes forthe effective maintenance and replacement of fluid deficits. Thiscomposition is especially advantageous for children to take who areunable to tolerate the liquid or frozen forms. The gel rehydrationelectrolyte composition of the invention is convenient, nonthreatening,painless, and easy to administer.

[0046] The gel rehydration electrolyte composition of the invention isadvantageously used to supply water and electrolytes needed to themaintenance and/or replacement of mild to moderate losses ofelectrolytes as in diarrhea or vomiting during illnesses. Such acomposition also provides a useful way of coaxing sick children orelderly such as those in a post-operative recovery period, into takingnecessary replenishing fluids.

[0047] In addition to being a useful therapeutic agent, the gelrehydration electrolyte composition of the invention is a particularlyuseful prophylactically. Ingestion of the gel rehydration electrolytecomposition helps to maintain proper electrolyte balance and to avoiddehydration.

[0048] The gel rehydration electrolyte composition of the invention ismade by first preparing a solution of potassium, sodium, chloride and abase in water. Suitable bases include acetate, lactate, citrate and/orbicarbonate. Sodium chloride, potassium citrate, sodium citrate, andpotassium chloride are suitable sources of electrolytes. Citric acid maybe also used. For the prevention of dehydration or maintenance ofhydration, sodium ion may be added at a concentration of 20-100 mEq/L,and typically a level of from 40-60 mEq/L is sufficient. Preferredpotassium levels are from 15-30 mEq/L, with a broad range of 10-100mEq/L being operable. The chloride anion is preferably added at 30-80mEq/L, with a broad range of 25-100 mEq/L being operable. The base,which is selected from the group consisting of acetate, lactate, citrateor bicarbonate, is preferably added to a range of 25-40 mEq/L, withbroad range of 20-50 mEq/L being operable.

[0049] A structuring agent is then added to the solution of potassium,sodium, chloride and a base in water. As used herein, the termstructuring agent means any gelling or thickening agent that can becombined with other necessary ingredients to provide a gel rehydrationelectrolyte composition having a preferred product consistency at roomtemperature. As used herein, the term preferred product consistency atroom temperature is defined as having a gel strength in the range offrom about 20 to about 1000 grams per cm², and preferably from about 100to about 200 grams per cm². Gel strength is measured by any convenientmethod known to those in the art, and typically is measured by agelometer.

[0050] In preparing a gel rehydration electrolyte composition for atypical gel strength test, a portion of water is heated and allnon-water ingredients are added. The mixture is stirred at elevatedtemperature until all non-water ingredients, including the structuringagent, are dissolved. Finally, the remaining water is added and theresulting mixture stirred with continued heating to about 185° F. Themixture is then removed from heat and poured into four 50 ml beakers,each filled to the 40 ml mark. The beakers are placed in a refrigeratorat 45° F. and equilibrated for two hours. The beakers are then removedfrom the refrigerator and gel strength readings are immediately takenusing a Stevens 1CM2 gelometer. The measured gel strength is the averageof the four readings.

[0051] Exemplary structuring agents include but are not limited to agar,alginates, carrageenan, in kappa, iota, or lambda form, cellulosederivatives, exudate gums, gellan gum, gelatin, guar gum, konjac gum,locust bean gum, microcrystalline cellulose, modified starches, pectins,seed gum, and xanthan gum. Preferred structuring agents include but arenot limited to gelling agents such as agar, alginate, carrageenan, andpectin. Preferred structuring agents also include but are not limited tothickening agents such as gum arabic, gum tragacanth, tamarind gum,taragum, guar, locust bean gum, and xanthan gum. A most preferredstructuring agent is Ticagel® 550, available commercially from TIC GumsInc., Belcamp, Md. Ticagel® 550 comprises a blend of carrageenan andlocust bean gum and produces a preferred composition consistency at roomtemperature when used in an amount of about 4.5 grams per liter.

[0052] Carrageenan is a naturally-occurring hydrocolloid consisting ofhigh molecular weight linear sulfated polysaccharides. It is obtainedcommercially by extraction from several related species of red algaeseaweed and is widely used in the food industry as a stabilizer andgelling agent. The most widely known carrageenans are lambda-, kappa-,iota-, mu-, and nu-carrageenans, described in particular in Janitsyn etal., Handbuch der Kosmetika und Reichstoffe, pages 181-82, VerlagHeidelberg, 1969. The average molecular weight of carrageenans isbetween 100,000 and 1,000,000.

[0053] Locust bean gum or Ceratonia Siliqua is cultivated along theMediterranean shore (Spain, Greece, Italy and North Africa). Locust beangum is a nonionic polysaccharide comprising straight chain mannangroupings with branching on every second mannose unit by one galactoseunit. Locust bean gum is partially soluble in cold water, and completelyhydrates when heated.

[0054] Either before or after the structuring agent is added, acarbohydrate such as glucose, dextrose, or fructose is added in anamount of about 20-25 grams per liter. Any carbohydrate used in priorart oral rehydration solutions may be used to practice the presentinvention. Suitable sugars include glucose, fructose and polymersthereof including corn syrup high fructose corn syrup, sucrose,maltodextrin and combinations thereof. Glucose, for example, not onlyhelps to promote sodium and water absorption but provides energy. Apreferred carbohydrate source is a mixture of crystalline fructose,sucrose and dextrose. The amount of carbohydrate depends on theselection thereof and is readily determinable by the skilled artisan.

[0055] The gel rehydration electrolyte composition of the inventionoptionally but preferably contains flavoring and/or sweetening agents.While individual perception of flavoring agents and sweetening agentsdepends on the interrelationship of many factors, flavors and sweetenersmay also be perceived separately. Thus, as is well known in the art,flavor and sweetener perception may be both dependent upon each otherand independent of each other. For example, when a large amount offlavoring agent is used, a small amount of sweetening agent may bereadily perceptible and vice versa. In general, the flavor and sweeteneris used in an amount effective to provide a desired taste. Such amountswill vary with the flavor and sweetener selected. The exact range ofamounts for each type of sweetener and/or flavoring is known in the artand/or is readily determinable by the skilled artisan.

[0056] Flavoring agents useful in preparing gel rehydration electrolytecompositions of the invention include those flavorings known to theskilled artisan, such as flavoring derived from plants, leaves, flowers,fruits, and the like and mixtures thereof. Representative flavor oilsinclude cinnamon oil and oil of wintergreen (methyl salicylate). Usefulflavorants include artificial, natural and synthetic fruit flavors suchas citrus oils, including lemon, lime, orange, grape and grapefruit, andfruit essences including apple, strawberry, raspberry, cherry,pineapple, tropical and the like, and mixtures thereof. Artificialflavorings are preferred for use in the practice of this invention.Particularly preferred flavors are artificial fruit flavors.

[0057] The sweetening agent used may be selected from a wide range ofmaterials including water-soluble sweeteners, water-soluble artificialsweeteners, water-soluble sweeteners derived from naturally occurringwater-soluble sweeteners, and mixtures thereof. Without being limited toparticular sweeteners, representative categories and examples include:

[0058] (a) water-soluble sweetening agents such as monosaccharides,disaccharides and polysaccharides such as monosaccharides, disaccharidesand polysaccharides such as xylose, ribulose, glucose (dextrose),mannose, galactose, fructose (levulose), sucrose(table sugar), maltose,invert sugar (a mixture of fructose and glucose derived from sucrose),partially hydrolyzed starch, corn syrup solids, dihydrochalcones,monellin, steviosides, glycyrrhizin, and sugar alcohols such assorbitol, mannitol, maltitol, hydroganated starch hydrolysates andmixtures thereof;

[0059] (b) water-soluble artificial sweeteners such as soluble saccharinsalts, i.e., sodium or calcium saccharin salts, cyclamate salts, thesodium, ammonium or calcium salt of3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide, the potassiumsalt of 3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one2,2-dioxide(Acesulfame-K), the form of sacchrin, and the like; and

[0060] (c) water-soluble sweeteners derived from naturally occurringwater-soluble sweeteners, such as chlorinated derivatives of ordinarysugar (sucrose), known, for example under the produce designation ofSucralose.

[0061] Preferred sugar based sweeteners are dextrose, sucrose, andfructose and mixtures thereof. Preferred sugarless sweeteners are sugaralcohols. Preferred sugar alcohols are selected from the groupconsisting of sorbitol, xylitol, maltitol, mannitol, and mixturesthereof. Particularly preferred sweetening agents include sucrose,dextrose, fructose, sucralose, acesulfame-k, dextrose, saccharine,aspartame, and high fructose corn syrup.

[0062] Sugars such as dextrose, sucrose, and fructose were earlierdescribed herein as being preferred carbohydrates due to their abilityto facilitate transport and aid absorption of the electrolytes in thegel. However, as just discussed, sugars can provide benefit aswater-soluble sweetening agents. When sugars such as dextrose, sucrose,and fructose are present in formulations prepared according to thepresent invention, such sugars can be serving solely as carbohydrate,solely as sweetening agent, or as both carbohydrate and sweeteningagent.

[0063] A coloring agent, if desired, can be used in an amount effectiveto produce the desired color. Coloring agents include pigments such asitanium dioxide. Particularly useful colorants include water-solublenatural food colors and dyes suitable for food, drug and cosmeticapplications. These colorants are known as F.D. & C. dyes and lakes.Illustrative nonlimiting examples include the indigoid dye known as F.D.& C. Blue No. 2, which is the disodium salt of 5,5-indigotindisulfonicacid. Similarly, the dye known as F.D.& C. Green No. 1 comprises atriphenyl-methane dye and is the monosodium salt of4-[4-(N-ethyl-p-sulfoniumbenzylamine)diphenylmethylene]-[1-(N-ethyl-N-p-sulfoniumbenzyl)-delta-2,5-cycohexadieeneimine]. A full recitation of all F.D.& C. colorants andtheir corresponding chemical structures may be found in the Kirk-OthmerEncyclopedia of Chemical Technology, 3^(rd) Edition, Volume 5, pages857-884.

[0064] A preferred gel rehydration electrolyte composition of theinvention comprises from about 4 to about 5 grams of Ticagel® 550; fromabout 20 to 30 grams of glucose or dextrose per liter; and about 45 mEq(1022 mg) of Na⁺, 20 mEq (784 mg) of K⁺, 40 mEq (1232 mg) of Cl and 30Meq (1918 mg) citrate ions per liter. This composition provides allelectrolytes at levels required by the American Academy of Pediatricsfor oral rehydration formulations sold in the United States.

[0065] The gel rehydration electrolyte composition may be in the form ofa dry solid that upon dissolution with an appropriate amount of waterprovides the above described gel rehydration electrolyte composition.The gel rehydration electrolyte composition may be packaged in a sealedplastic container that can be refrigerated and subsequently opened sothat the gel may be sucked from the container. Alternatively, andpreferably, the gel rehydration electrolyte formulation may be packaged,shipped, and consumed at room temperature in containers containing adesired dose, generally about 2-8 ounces, suitable for spoon feeding.

[0066] Gel rehydration electrolyte compositions of the invention mayalso optionally contain various pharmacological agents such as, forexample, an antibiotic. If desired, the gel rehydration electrolytecomposition may also contain bioavailable minerals, anabolic nutrients,antioxidants, vitamins, analgesics, and/or suspending agents. Examplesof anabolic nutrients include vanodyl sulfate, alphaketoglutarate,inosine. Examples of antioxidants include carotenoids, ascorbic acid andsalts thereof, tocopherols, reduced glutathione and coenzyme Q10. Asreferred to herein, bioavailable minerals include inorganic substances,metals, and the like, required in the human diet. Suitable mineralsinclude manganese chromium, calcium, iron, zinc, selenium, copper,iodine, magnesium, phosphorus, and the like such as magnesium oxide,calcium carbonate, ferrous sulfate, ferrous fumarate, zinc chloride,cupric chloride, calcium iodate; and mixtures thereof. Such minerals maybe present as amino acid chelates. An amino acid chelate is defined inthe food art as a metal ion from a soluble salt with an amino acid orpeptide ligand with a mole ratio of one mole of metal to one to three,preferably two, moles of amino acides to form coordinate covalent bonds.

[0067] The term vitamin, as used herein, refers to trace organicsubstances that are required in the diet and include, withoutlimitation, thiamin riboflavin, nicotinic acid, patothenic acid,pyridoxine, biotin, folic acid, vitamin B₁₂, lipoic acid, ascorbic acid,vitamin A, vitamin D, vitamin E and vitamin K. Also included with theterm vitamin are the coenzymes thereof. Coenzymes are specific chemicalforms of vitamins.

[0068] Coenzymes include tiamine pyrophosphates (TPP), flavinmononucleotide (FMM), flavin adenine dinucleotide (FAD), nicotinamideadenine dinucleotide (AND), nicotinamide adenine dinucleotide phosphate(NADP) Coenzyme A (CoA) pyridoxal phosphate, biocytin, tetrahydrofolicacid, coenzyme B₁₂, lipolysine, 11-cis-retinal, and1,25-dihydroxycholecalciferol. The term vitamin also includes choline,camitine, and alpha beta, and gamma carotenes.

[0069] Analgesics include narcotic and non-narcotic analgesics.Exemplary narcotic analgesics include but are not limited to hydrocodoneand acetaminophen. Exemplary non-narcotic analgesics include but are notlimited to ibuprofen and ultram.

[0070] The gel rehydration electrolyte composition of the presentinvention may be packaged in numerous advantageous ways. It may bepackaged as a dry powder to which water is added. It may be packaged inready-to-consume individual dosages suitable for spoon feeding. It mayalso be packaged in a sealed flexible plastic container that can beopened at one end so that the contents may be sucked out. Preferably,the gel rehydration electrolyte composition is provided as a unit dosepackaged in a plastic cup and to be spooned out by consumers.

[0071] All documents, e.g., patents, journal articles, and textbooks,cited above or below are hereby incorporated by reference in theirentirety.

[0072] One skilled in the art will recognize that modifications may bemade in the present invention without deviating from the spirit or scopeof the invention. The invention is illustrated further by the followingexamples, which are not to be construed as limiting the invention inspirit or scope to the specific procedures or compositions describedtherein.

EXAMPLE 1

[0073] A gel rehydration electrolyte composition was prepared containingthe following ingredients: Ingredient Percent by weight Water, flavorand color 96.185 Dextrose 2.473 Citric Acid 0.457 Potassium citrate0.152 Potassium sorbate 0.039 Sodium benzoate 0.020 Salt 0.219 Sodiumcitrate 0.030 Acesulfame Potassium 0.075 Ticagel ® 550 0.450

[0074] The gel rehydration electrolyte composition was prepared byheating 32 parts of water and dissolving therewithin the sodium benzoateand potassium sorbate. The remaining non-water ingredients were thenadded and dissolved. Finally, the remaining water was added and theresulting mixture was cooled. The mixture gelled upon cooling andprovided a gel rehydration electrolyte composition suitable for spoonfeeding.

[0075] The invention and the manner and process of making and using it,are now described in such full, clear, concise and exact terms as toenable any person skilled in the art to which it pertains, to make anduse the same. Although the foregoing describes preferred embodiments ofthe present invention, modifications may be made therein withoutdeparting from the spirit or scope of the present invention as set forthin the claims. To particularly point out and distinctly claim thesubject matter regarded as the invention, the following claims concludethis specification.

What is claimed is:
 1. A gel rehydration electrolyte compositioncomprising: (a) from about 80 to about 99 percent by weight water; (b)from about 20 to about 60 mEg of sodium per liter of water; (c) fromabout 15 to about 25 mEq of potassium per liter of water; (d) from about25 to about 50 mEq of chloride per liter of water; (e) from about 20 toabout 50 mEq of citrate per liter of water; (f) from about 20 to about30 grams of carbohydrate per liter of water; and (g) from about 2 toabout 10 grams of a structuring agent per liter of water.
 2. The gelrehydration electrolyte composition of claim 1, wherein the structuringagent is selected from the group consisting of agar, alginates,carrageenan, cellulose derivatives, exudate gums, gellan gum, gelatin,guar gum, konjac gum, locust bean gum, microcrystalline cellulose,modified starches, pectins, seed gum, and xanthan gum.
 3. The gelrehydration electrolyte composition of claim 1, wherein the structuringagent is a combination of carrageenan and locust bean gum.
 4. The gelrehydration electrolyte composition of claim 1 comprising 45 mEq ofsodium per liter of water; 20 mEq of potassium per liter of water; fromabout 35 to about 40 mEq of chlorine per liter of water; and from about25 to about 30 mEq of citrate per liter of water.
 5. The gel rehydrationelectrolyte composition of claim 1 comprising about 25 grams ofcarbohydrate per liter.
 6. The gel rehydration electrolyte compositionof claim 1 further comprising coloring and flavoring agents.
 7. A drypowder which upon the addition of an amount of water provides acomposition comprising: (a) from about 80 to about 99 percent by weightwater; (b) from about 20 to about 60 mEg of sodium per liter of water;(c) from about 15 to about 25 mEq of potassium per liter of water; (d)from about 25 to about 50 mEq of chloride per liter of water; (e) fromabout 20 to about 50 mEq of citrate per liter of water; (f) from about20 to about 30 grams of carbohydrate per liter of water; and (g) fromabout 2 to about 10 grams of a structuring agent per liter of water. 8.The gel rehydration electrolyte composition of claim 1, wherein thecomposition is spoonable at room temperature.
 9. The gel rehydrationelectrolyte composition of claim 1, wherein the composition is containedin a sealed flexible plastic container which can be opened so that thegel may be orally administered to a patient.
 10. A method of replacinglost electrolytes or preventing loss of electrolytes comprising orallyadministering to an individual in need thereof a gel rehydrationelectrolyte composition comprising: (a) from about 80 to about 99percent by weight water; (b) from about 20 to about 60 mEg of sodium perliter of water; (c) from about 15 to about 25 mEq of potassium per literof water; (d) from about 25 to about 50 mEq of chloride per liter ofwater; (e) from about 20 to about 50 mEq of citrate per liter of water;(f) from about 20 to about 30 grams of carbohydrate per liter of water;and (g) from about 2 to about 10 grams of a structuring agent per literof water.
 11. The method of claim 10, wherein the structuring agent is acombination of carrageenan and locust bean gum.